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COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

Positive data from phase IIb study shows potential of COMP360 psilocybin therapy
in treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans*. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

The randomised, controlled, double-blind phase IIb clinical trial was designed to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg in patients with treatment-resistant depression (TRD). 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS)**, a widely used and accepted scale for assessing depression; the MADRS assessments were made by an independent, blinded rater.

Key results:

  • Depression symptoms: patients who received a 25mg dose of COMP360 psilocybin with psychological support experienced a highly statistically significant reduction in symptoms of depression after three weeks: the difference between 25mg group and 1mg group was -6.6 on the MADRS* depression scale at week 3, p<0.001.
  • Durability: double the number of patients who received 25mg had a sustained response at week 12, compared to those who received 1mg (20.3% of patients in the 25mg group vs 10.1% in the 1mg group).
  • Tolerability: COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the only adverse events where a dose-related increase in incidence was evident and there were no clinically significant differences between dose group in vital signs or clinical laboratory tests observed during the study.
  • Adverse events: In this study suicidal ideation and intentional self-injury were seen in all treatment groups (as is regularly observed in a TRD population), and the majority occurred more than a week after the psilocybin session. There was no mean worsening of suicidal ideation scores in any treatment group. Suicidal behaviours were reported at least 1 month after COMP360 administration for 3 non-responders in the 25mg arm.

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is one of the biggest challenges we face in psychiatry, and chances of success decreases with each treatment that a patient tries. It’s rare to see such positive outcomes of clinical trials in this disease area, which is why these results are so significant. I hope this represents a major step in finding new options for people living with treatment-resistant depression.”

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, “Our mission is all about developing mental health innovations through scientific evidence, which is why we’re so honoured to present the largest study of its kind at the APA. In this study, a significant number of patients experienced improvement in their symptoms of depression after just a single dose of 25mg psilocybin with psychological support, with effects lasting for up to three months of the study. We now need to continue our research to understand if this can be replicated in even larger trials.”

Hear Professor David Hellerstein talk about the study

-Ends-

*The safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression: Results from a phase IIb randomized controlled trial. Guy M. Goodwin, Susan C. Stansfield, David J. Hellerstein, Allan H. Young, Ekaterina Malievskaia. APA: Abstract Number: 5301 Session Title: Poster Session 6

**MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; sustained response = patients meeting the MADRS response criteria from week 3 until week 12

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)1, the leading cause of disability worldwide and one of the fastest growing mental health illnesses2. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)3. As many as 30% of these attempt suicide at least once during their lifetime4,5. TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients6. The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

About the COMP360 psilocybin therapy phase IIb study

This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.

About COMPASS Pathways              

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

References:

[1] WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
[2] WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
[3] Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
[4] Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
[5] Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
[6] Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23.

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COMPASS Pathways plc announces first quarter 2022 financial results and business highlights

COMPASS Pathways plc announces first quarter 2022 financial results and business highlights

Highlights:

  • End of phase II meeting held with FDA
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway ILAP
  • Finalising phase III in TRD program design to be ready for second half of 2022
  • Pioneering collaboration with King’s College London and South London and Maudsley NHS Foundation Trust, to create The Centre for Mental Health Research and Innovation in the UK
  • Cash position at 31 March 2022 of $243.7 million
  • Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2022 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “COMPASS made great progress this quarter including a productive end-of-phase II FDA meeting and we are actively working to finalise our phase III programme,. Moreover, we continue to push the boundaries of brain health research as we broaden our pipeline and partnerships. This includes our clinical trial of COMP360 therapy in post-traumatic stress disorder, or PTSD, a condition of significant unmet need for improved patient outcomes. Our strong cash position enables us to move forward at pace.”

Business highlights

COMP360 psilocybin therapy in treatment-resistant depression (TRD):

  • Positive results from groundbreaking phase IIb clinical trial
  • Positive results from open-label study of 25mg COMP360 psilocybin therapy as adjunct to selective serotonergic reuptake inhibitor, or SSRI, antidepressants
  • End-of-phase II meeting held with FDA in April 2022
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway (ILAP).
  • Finalising Phase III in TRD programme to be ready for second half of 2022
  • FDA granted breakthrough therapy designation
  • 10 granted patents issued to date covering composition, formulation and method of use

Additional COMP360 development programmes:

  • Phase II trial in PTSD ongoing at Kings College London
  • Investigator-led study in adults with autism spectrum disorder (ASD) announced, the first ever study of psilocybin in adults with ASD, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust
  • Positive early signals seen in investigator-initiated studies in anorexia nervosa and severe treatment-resistant depression, presented at the Society of Biological Psychiatry Annual Meeting in New Orleans
  • Investigator-initiated studies underway across additional indications including new study in autism sponsored
  • Identification of new potential novel drug candidates through the COMPASS Discovery Center and an exclusive research project with Dr Matthias Grill
  • Strategic partnership formed to launch The Centre for Mental Health Research and Innovation to accelerate research and develop new models of mental healthcare in the UK

Financial highlights

  • Net loss for the three months ended 31 March 2022 was $21.2 million, or $0.50 loss per share (after including non-cash share-based compensation expense of $3.1 million), compared with $12.7 million or $0.35 loss per share, during the same period in 2021 (after including non-cash-share-based compensation expense of $1.7 million).
  • R&D expenses were $15.4 million for the three months ended 31 March 2022, compared with $6.9 million during the same period in 2021. Of this increase, $5.1 million was attributable to increased external development expenses as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. A further $2.6 million and $1.0 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. This was partially offset by a decrease of $0.2 million in other expenses.
  • G&A expenses were $10.1 million for the three months ended 31 March 2022 compared with $6.7 million during the same period in 2021. The increase was attributable to an increase of $1.0 million and $0.5 million in personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was a further increase of $1.4 million in legal and professional fees and $0.4 million in facilities and other expenses.
  • Cash and cash equivalents were $243.7 million as of 31 March 2022 compared with $273.2 million as of 31 December 2021.

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 10 May 2022. The call can be accessed by dialing 1-800-926-7358 from the United States, 1-212-231-2914 internationally, and 0800-496-0823 from the UK, followed by the conference ID: 22018578

The call will also be webcast on the COMPASS Pathways website and archived for 30 days. For more information, please visit the COMPASS Pathways website (ir.compasspathways.com).
 

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com
 

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
 

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’s business strategy and goals, and COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, development efforts and innovation labs. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; our development efforts and our business strategy to set up research facilities and innovation labs will involve significant costs and resources and may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Annual Report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.
 

Enquiries

Media: Lindsay Complin, lindsay.complin@compasspathways.com, +44 7702 191328
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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Understanding neurodiversity

COMPASS Pathways to fund study of COMP360 psilocybin in autistic adults

COMPASS Pathways (CMPS) is funding a psilocybin study to better understand the brain science of neurodiversity.

Using brain imaging and behavioural tasks, researchers will investigate how psilocybin affects the serotonin brain networks in autistic adults compared to non-autistic adults. 

The goal is to understand the unique brain mechanisms associated with autism to provide “better tailored choices” to autistic people.

CMPS shares spiked 11% yesterday after the company announced Q1 financial results, including $21.2M net loss and $243.7M in cash.

PDF of article

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COMPASS Pathways plc to announce first quarter 2022 financial results on 10 May 2022

COMPASS Pathways plc to announce first quarter 2022 financial results on 10 May 2022

LONDON, May 03, 2022 (GLOBE NEWSWIRE) — COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the first quarter 2022, and provide an update on recent business developments on 10 May 2022.

The management team will host a conference call at 8:00am ET (1:00pm UK) on 10 May. The call can be accessed by dialing (800) 926-7358 from the United States, +1 (212) 231-2914 internationally, and 0800 496 0823 from the UK, followed by the conference ID: 22018578.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.        

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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COMPASS announces new psilocybin therapy findings

COMP360 psilocybin therapy shows potential in exploratory open-label studies for anorexia nervosa and severe treatment-resistant depression

New studies suggest that COMPASS Pathways’ proprietary psilocybin has promise in treating some of the most challenging mental health conditions: severe treatment-resistant depression and anorexia nervosa.

After a single dose of psilocybin, 58.3% of patients with severe treatment-resistant depression (meaning they’d tried 5+ antidepressant treatments without success) had a reduction in depression scores for 12 weeks.

One quarter of patients no longer qualified for a depression diagnosis.

In the anorexia study, 30% of patients had significant reductions in symptoms at the 1-month follow up, increasing to 40% at the 3-month follow up.

PDF of article

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Attention psychedelic researchers 🚨

Here’s two new opportunities to get your research funded:

  1. COMPASS Pathways (CMPS) is sponsoring three One Mind Rising Star Awards – a $300,000 research grant for mental health researchers.
  2. The Canadian Institutes of Health Research (CIHR) is launching a $3M grant program to support psilocybin clinical trials on:
  • Substance use disorders
  • Major depressive disorder or treatment resistant depression
  • End-of-life distress in late-stage cancer patients

PDF of article 1

PDF of article 2

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COMPASS Pathways partners with One Mind to fund Rising Star Awards for the next generation of mental health researchers

COMPASS Pathways partners with One Mind to fund Rising Star Awards for the next generation of mental health researchers

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it is partnering with One Mind, a leading mental health research non-profit based in California, to sponsor three “2022 One Mind – COMPASS Rising Stars Awards”.

The One Mind Rising Star Awards are given each year to promising early career investigators who are pursuing research with the potential to dramatically advance the understanding and treatment of mental illnesses, and to improve patient outcomes. A Request for Applications was issued by One Mind today and up to three winners will be selected by One Mind’s Scientific Advisory Board through a competitive process. The winners, to be announced in September 2022, will each receive a $300,000 research grant sponsored by COMPASS over three years. They will also be eligible to participate in select leadership development and entrepreneurship opportunities through the One Mind Rising Star Development Program offered by One Mind.

Brandon Staglin, President, One Mind, said, “Since 2005, One Mind has awarded 40 Rising Star Awards to some of the best and brightest early-career brain scientists. We want to catalyse innovation and encourage collaboration and data-sharing so that we can make an impact on some truly devastating illnesses. We are delighted to be working with COMPASS, whose mission and values, and single-minded focus on patient care, fit so well with everything we do at One Mind.”

This partnership with One Mind is aligned to COMPASS’s commitment to identify and support world class talent in neuroscience and mental health research. COMPASS is a founding supporter of the British Neuroscience Association’s inaugural Scholars programme which supports scientists from under-represented ethnic groups. COMPASS also funds several PhD students in neuroscience in leading institutions in the US and Europe.

Ekaterina Malievskaia MD, Chief Innovation Officer and Co-founder, COMPASS Pathways, said, “Many of us at COMPASS know first-hand how difficult it can be to live with a mental health disorder. We have long admired the work that One Mind does in pushing the boundaries of brain health research and supporting high-risk innovation. We are excited about this collaboration and look forward to supporting the next generation of brain research scientists.”

-Ends-

About COMPASS Pathways       

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including  COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

About One Mind   

One Mind is a leading mental health non-profit that heals lives through brain research, working from science to services to society. By bringing together the best minds in brain science and advocacy around our collective vision of “Accelerating Brain Health for All”, One Mind is advancing a three-pronged program strategy of accelerating discoveries, scaling implementation and transforming societal culture. Together, we are creating a world where all individuals facing brain health challenges can build healthy, productive lives. www.onemind.org

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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COMPASS Pathways to participate in Needham Healthcare conference

COMPASS Pathways to participate in Needham Healthcare conference

LONDON, April 04, 2022 (GLOBE NEWSWIRE) — COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of its management team will present at the 21st Annual Needham Virtual Healthcare Conference at 2:15pm ET on 14 April 2022.

A webcast of the presentation will be available on the “Events” page of the Investors section of the COMPASS website. A replay of the webcast will be available for 30 days following the event. For more information, please visit ir.compasspathways.com.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com.

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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COMPASS Pathways and partners launch The Centre for Mental Health Research and Innovation, in the UK

COMPASS Pathways and partners launch The Centre for Mental Health Research and Innovation, in the UK

Pioneering collaboration with King’s College London and South London and Maudsley NHS Foundation Trust

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has formed a long-term strategic partnership to launch The Centre for Mental Health Research and Innovation (“the Centre”) to accelerate psychedelic research and develop new models of care for mental health in the UK.

Together with South London and Maudsley NHS Foundation Trust (SLaM), the largest mental health trust in the UK National Health Service (NHS) and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, this pioneering collaboration will provide patient access to cutting edge research studies in multiple areas of high unmet need in mental health.

The Centre will accelerate research of emerging psychedelic therapies, support therapist training and certification, evaluate real-world evidence, and prototype digital technologies to enable personalised, predictive and preventative care models.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “In 2021, the UK Government included mental health care as a core pillar of its Life Sciences Vision – a signal of how critical an issue this is becoming. We are grateful to be able to play a part in this, and to be working with SLaM and the IoPPN, UK leaders in patient care and research in mental health. The Centre will accelerate the integration of innovative psychedelic therapies into the NHS following regulatory approval and reimbursement. It is a key part of our strategy to work with health systems to develop innovative evidence-based therapies, and ensure they reach those who might benefit from them as quickly as possible.”

Research will initially focus on COMPASS’s investigational COMP360 psilocybin therapy and supportive technologies, and will also cover other novel therapeutic approaches being researched and developed by COMPASS, in areas of significant unmet mental health need including treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and anorexia nervosa.

The ambition is for the Centre to be a beacon of innovative mental health care models, and help inspire and accelerate the development of such public-private partnerships among industry sponsors, academic investigators and the NHS under the Mental Health Mission within the new UK Government Life Sciences Vision. The Centre will initially be located at Maudsley Hospital, London, while state-of-the-art facilities are built within a 200 acre woodland at Bethlem Royal Hospital, London. This dedicated and purpose-built space for late-stage clinical trials will be managed by leading clinical investigators with extensive experience in conducting psychedelic clinical trials, and will provide access to COMP360 psilocybin therapy to an estimated 650-700 patients over a five-year term.

David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust, said, “We are seeing a rapid growth in the number of people with mental health care needs, in South London and across the UK. We are proud to continue our legacy of innovation and research by partnering with COMPASS Pathways to directly translate research into healthcare treatment and significantly improve care in our communities.”

Professor Allan Young, Head of Academic Psychiatry at King’s IoPPN, said, “This new Centre is all about putting patients first. The collaboration with COMPASS Pathways will focus on developing new and effective therapies, as well as considering the patient experience in the real world. We hope it will pave the way for how research and innovations partnerships are developed in the future.”

-Ends-

About COMPASS Pathways    

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of psilocybin therapy, including COMP360, as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s expectations and plans regarding the Centre, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, and COMPASS’s expectations regarding the benefits of psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience

King’s College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and 8,500 staff. King’s has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain.

www.kcl.ac.uk/ioppn @KingsIoPPN

About South London and Maudsley NHS Foundation Trust

South London and Maudsley NHS Foundation Trust is a large and complex multi-site provider of mental health services – providing the widest range of NHS mental health services in the UK. We aim to make a difference to people’s lives by seeking excellence in all areas of mental health and wellbeing. Our 6,000 staff serve a local population of 1.3 million people and we offer more than 260 services including inpatient wards, outpatient and community services across Lambeth, Lewisham, Southwark and Croydon. We also provide substance misuse services for people who are addicted to drugs and alcohol. As well as serving the communities of south London, we provide more than 20 specialist services for children and adults across the UK including perinatal services, eating disorders, psychosis and autism.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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COMPASS Pathways announces financial results for the fourth quarter and full year 2021 and business highlights

COMPASS Pathways announces financial results for the fourth quarter and full year 2021 and business highlights

COMPASS Pathways (CMPS) reported 2021 financial results including a net loss of $71.7 million ($1.79 loss per share) and $273.2M in cash. The company had a $60.3M loss ($3.55 loss per share) and $190.3M in cash in 2020.

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